Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL-R2-B2)

Approximately 20% of patients diagnosed with Hodgkin lymphoma will eventually experience progression or relapse after first-line treatment, which carries a significant risk of disease-related death. Although several pilot studies have demonstrated high rates of sustained response with the combination of brentuximab vedotin (BV) and chemotherapy, consistent real-world data are still lacking. Moreover, there is no universally accepted salvage chemotherapy regimen in this setting, and clinical practices vary across centers. This study aims to describe the efficacy and toxicity of the BV + bendamustine (B2) regimen in patients with relapsed/refractory Hodgkin lymphoma (R/R HL) treated in France over a 10-year period, with or without an attempt at consolidative transplantation.

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Key information

Conditions

Relapsed or Refractory Hodgkin Lymphoma Disease Attributes Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH de la Côte Basque, service Hématologie Clinique, Bayonne, France

About this study

This study is a retrospective observational multicentric study. All patients fulfilling inclusion criteria in participant centers will be included. Clinical data will be obtained from patients medical records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient with relapsed or refractory HL, after at least one first line of treatment
Aged 18 years and over
Having received at least one course of the Brenxutimab-Vedotin J1 and Bendamustine J1 + J2 combination

Exclusion criteria

Minor patients
Pregnant women

Treatment and study plan

Brentuximab-Vedotin associated with Bendamustine

Drug

Patient having received at least one course of the association Brentuximab-Vedotin and Bendamustine

Primary outcomes

Progression free survival (PFS) for the whole cohort

Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Measured from the time of treatment initiation to the date of event : progression or death

Secondary outcomes

Overal survival (OS) for the whole cohort

Time frame: From date of inclusion until the date of death from any cause assessed up to 120 months

Measured from the time of treatment initiation to the date of death

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma

Acronym: HL-R2-B2

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 28, 2025
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed